Kornimate/medical-research-clean huggingface dataset:
heart arteries and sickle cell disease / coeur artères drepanocytose

Conditions: Sickle Cell Anemia; Sickle Cell Disease

Summary: the cadre study is a multinational observational cohort of patients with sickle-cell disease (scd) in five west and central sub-saharan african countries. the aim of this project is to describe the incidence and assess the predictive factors of scd-related micro- and macro-vascular complications in sub-saharan africa.

sickle cell disease (scd), one of the lost common genetic diseases worldwide, is caused by a mutation in the β globin gene. most patients with this disease are homozygous for the βs allele (ss), whereas others have inherited a βs allele with another mutation in the β globin gene. in addition to repeated acute ischemic insults due to the red blood cells sickling in the microcirculation, a chronic vasculopathy leads to organ injuries, such as kidney disease, stroke, pulmonary hypertension, retinopathy, bone infarcts, and leg ulcers. cadre is a multinational prospective observational study undertaken in five countries in sub-saharan africa. patients with scd will be recruited through outpatients' clinics in public, university and private hospitals and research centers in five countries. the cadre protocol was approved by the relevant national ethics committee in each of the participating countries. primary endpoint is to measure the prevalence and the incidence of the main vascular complications in the main types of scd: glomerulopathy, nephropathy, cardiopathy, pulmonary hypertension, retinopathy, strokes, osteonecrosis and leg ulcers. secondary endpoints are: * to define the clinical and biological predictors of scd vasculopathy in africa * to search for genetic risk factors for the scd-related cardiovascular complications, in particular alpha thalassemia, persistence of foetal hemoglobin and other candidate genetic polymorphisms * to search for functional risk factors (pulse wave velocity, capillary vasodilatation, blood visosity) for the scd-related cardiovascular complications * to search for new biological determinant of scd-related cardiovascular complications, in particular alternative markers of hemolysis (microparticules, free heme) and inflammation (cytokines, leucocytes phenotyping, net (neutrophile extracellular traps))

Eligibility criteria:
inclusion criteria: * age: five-year-old or more * signature of informed consent patients : major sickle cell syndrome confirmed by hemoglobin phenotyping: ss, sc, sbeta+ or sbeta0 controls : healthy parents or siblings of the patients, hospital staff or their children, matched on age+/- 3 years and country (1 control for 4 patients) exclusion criteria: unstable clinical status such as: * vaso-occlusive crisis in the previous 15 days * fever or infectious disease in the previous 15 days * transfusion in the previous 2 months

Keywords: sub-saharan africa sickle cell disease vasculopathy nephropathy pulmonary hypertension cardiac disease hemolysis pulse wave velocity blood viscosity
benefit extension study

Conditions: Multiple Sclerosis

Summary: to assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of ms.


Eligibility criteria:
inclusion criteria: * all patients randomized and treated at least once in study 304747 exclusion criteria: * medical, psychiatric or other conditions that compromise the patient's ability to understand the purpose of the study
natural history study in pediatric patients with mybpc3 mutation-associated cardiomyopathy

Conditions: Cardiomyopathy

Summary: the objective of this study is to collect information on patients with cardiomyopathy (cm) due to mutations in the mybpc3 gene, to evaluate their disease course, burden of illness, risk factors for this disease, and the quality of life (qol). this study will also collect information on treatments, procedures and outcome in infants and children up to 18 yrs who have this mutation.


Eligibility criteria:
retrospective inclusion criteria: * data is available for patient \<18 years of age. patients must be \<18 years of age at enrollment or at time of death. * documented results of genotyping showing the presence of at least one pathogenic or likely pathogenic mybpc3 mutation (heterozygous, homozygous, or compound heterozygous). exclusion criteria: * patient received cardiac transplantation or died \>10 years before study initiation. for homozygous or biallelic infants, data may be collected beyond this 10-year period. prospective inclusion criteria: for infants: * infants who are homozygous or compound heterozygous for the known pathogenic truncating mybpc3 mutations are eligible. for all other participants: * age \<18 at entry into the prospective study. * documented results of genotyping identifying at least one pathogenic or likely pathogenic mybpc3 mutation (heterozygous, homozygous, or compound heterozygous). * diagnosis of cardiomyopathy (cm): hcm, dcm, rcm, mixed cm, or lvnc. exclusion criteria: * concurrent participation in an interventional clinical trial unless approved by the sponsor. * severe noncardiac disease anticipated to significantly reduce life expectancy.

Keywords: genetic cardiomyopathy pediatric mybpc3 hypertrophic cardiomyopathy (hcm) dilated cardiomyopathy restrictive cardiomyopathy non-compaction cardiomyopathy
a randomized phase iii trial comparing folfirinox to gemcitabine in locally advanced pancreatic carcinoma

Conditions: Pancreatic Cancer; Carcinoma

Summary: french national multicentric phase iii trial evaluating chemotherapy with folfirinox or gemcitabine in locally advanced pancreatic carcinoma.

comparative interventional prospective phase 3, randomized, open-label, multicentric trial comparing chemotherapy with folfirinox to gemcitabine in locally advanced pancreatic carcinoma.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed adenocarcinoma of the pancreas 2. proven unresectability after multidisciplinary discussion involving radiologist and a surgeon 3. locally advanced (i.e.: no metastasis or suspicion of metastasis) and unresectable tumors: for example mesenteric or portal vein involvement, or \> 180° encasement of the superior mesenteric artery, or celiac abutment (nccn 2012 criteria) 4. measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral ct scan according recist 1.1 5. who performance status (ps) 0-1 6. age ≥18 years 7. patient with organ function as follows: * absolute neutrophil count (anc) ≥ 1.5 x 10⁹/l * hemoglobin ≥ 10 g/dl * platelets (ptl) ≥ 75 x 10⁹/l * aspartate aminotransferase (ast) / alanine aminotransferase (alt) ≤ 2.5 x upper limit of normal (uln) * bilirubin ≤ 1.5 x uln * creatinine ≤ 2 x uln * albumin \> 0.75 x lower limit of normal (lln) * urea ≤ 2 x uln 8. adequate vital functions 9. patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use medically acceptable methods of contraception during the study and for 4 months after the last intake of study treatment for women and for 6 months after for men. 10. patient information and signed informed consent form 11. public or private health insurance coverage 12. uracilemia \< 16 ng/ml exclusion criteria: 1. patient treated for a cancer other than pancreatic cancer within 5 years before enrolment, with the exception of basal cell carcinoma or in situ cervical cancer 2. patient with metastasis or with history of metastasis 3. patient with grade iii/iv cardiac problems as defined by the new york heart association criteria. (i.e. congestive heart failure, myocardial infarction within 6 months before baseline) 4. major comorbidity, active infection (hiv or chronic hepatitis b or c) or uncontrolled diabetes that may preclude the delivery of the treatment 5. pre-existing neuropathy (grade ≥ 2), gilbert's disease or genotype ugt1a1 \* 28 / \* 28 6. pregnant woman 7. fructose intolerance 8. patients currently treated by warfarin 9. persons deprived of liberty or under guardianship 10. psychological condition, family-, sociological- or geographical situation potentially hampering compliance with the study protocol and the follow-up schedule

Keywords: locally advanced pancreatic carcinoma folfirinox
a pilot randomized controlled trial to reduce salt intake among hypertensive young adults in hong kong

Conditions: Hypertension

Summary: a pilot randomized controlled trial will be conducted to investigate the feasibility and effectiveness of a salt intake reduction intervention to young hypertension patients in hong kong who had high salt intake.

convenience sample will be recruited from the community in hong kong through different channels of promotion.

Eligibility criteria:
inclusion criteria: * i) adults aged 18 to 44 * ii) diagnosed hypertension or borderline hypertension * iii) complete collection of 24-hour urine at baseline * iv) 24-hour urinary sodium excretion above 2000mg at baseline * v) can communicate in cantonese exclusion criteria: * i) renal illnesses; * ii) taking diuretics; * iii) taking ras blockers; * iv) attending or planning to attend new hypertension education programme or salt intake reduction programme during the study period.

Keywords: dietary salt 24 hour urinary sodium excretion blood pressure hypertension
clarity extension study

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within trial 25643 (clarity). this trial also explored clinical benefit of prolonged 192-week versus 96-week treatment.


Eligibility criteria:
inclusion criteria: * randomized in trial 25643 and satisfied one of the following: * completed randomized treatment course and scheduled visits for the full 96 weeks; or * did not complete the randomized treatment course in trial 25643 but elected to receive rescue treatment with rebif®, another beta-interferon, or glatiramer acetate and completed scheduled clinic visits for the full 96 weeks; or * did not complete the randomized treatment course in trial 25643, declined rescue with rebif®, another beta-interferon, or glatiramer acetate and still completed scheduled clinic visits for the full 96 weeks; or * did not complete the randomized treatment course in trial 25643, were not eligible for rescue option with rebif®, and still completed scheduled clinic visits for the full 96 weeks * male or female, between 18 and 65 years of age (inclusive, at time of informed consent for trial 25643) * no medical history or evidence of latent tuberculosis infection (ltbi) or tuberculosis (tb), as evidenced by tb skin test or chest x-ray * all of the following laboratory hematologic parameters evaluated as normal (as define below, inclusively) within 28 days of first dosing of blinded study medication at study day 1: * hemoglobin = 11.6 to 16.2 gram per deciliter (g/dl) * leukocytes (total white blood cell) = 4.1 to 12.3\*10\^3 per microliter * absolute lymphocyte count (alc) = 1.02 to 3.36\*10\^3 per microliter * absolute neutrophil count (anc) = 2.03 to 8.36\*10\^3 per microliter * platelet count = 140 to 450\*10\^3 per microliter * other protocol-defined inclusion/exclusion criteria may apply exclusion criteria: * participants who were not enrolled in trial 25643 * participant has moderate to severe renal impairment * use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab at any time during and since trial 25643 * use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (ivig) or plasmapheresis at any time during and since trial 25643 * treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days before study day 1
photodynamic therapy in occult-only lesions (pool)

Conditions: Age-Related Macular Degeneration

Summary: age related macular degeneration is the leading cause of blindness for people over 50 in the western world. blood vessels which start to grow form a lesion in the back of the eye. verteporfin may stabilize the disease, by closing the blood vessels. this study will assess the efficacy and safety of verteporfin in patients with occult only lesions.


Eligibility criteria:
inclusion criteria: * 50 years or older * must see better or equal to 34 letters (visual acuity) * choroidal neovascularization (cnv) lesion must be occult only exclusion criteria: * evidence of classic cnv in the lesion * prior treatment of disease in study eye * have a history of moderate to severe hepatic impairment other protocol-defined exclusion criteria may apply.

Keywords: age related macula degeneration, amd, choroidal neovascularisation (cnv), occult cnv lesion, verteporfin for injection, photodynamic therapy (pdt)
effect of time-restricted eating on blood glucose and behavior in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: diet management could improve blood and weight control in patients with diabetes mellitus. time-restricted feeding is a novel dietary tool that limits time of energy intake without altering diet quality or quantity. this study aims to assess the effect of 10-hour time-restricted feeding on metabolism and behavior in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: 1. diagnosed with type 2 diabetes mellitus 2. hba1c 7.0% to 8.5% 3. bmi ≥ 24 kg/m2 4. time of energy intake ≥ 12 hours per day, ≥ 4 days per week 5. ability to use smart phone and app, to follow study protocol 6. sign informed consent exclusion criteria: 1. use insulin, long-acting insulin secretagogues, glp-1 receptor agonist, dpp-4 inhibitor, sglt-2 inhibitor 2. suffer from disease influence eating: mental disease, subtotal gastrectomy, inflammatory bowel disease, uncontrolled thyroid disease 3. work state affect eating time: constant night duty, constant long-haul international travel 4. smoking 5. drinking 6. severe disease: severe cardiovascular and cerebrovascular disease, uncontrolled arrhythmia, heart failure, acute and chronic renal dysfunction, liver cirrhosis, malignancy, anemia 7. suffered from infectious disease: pulmonary tuberculosis, aids 8. dyskinesia 9. body weight change ≥ 5 kg in the past 3 months 10. hospitalized in the past 3 months 11. used antibiotics for ≥ 3 days in the past 3 months 12. diagnosed with type 1 diabetes mellitus 13. pregnancy, lactating 14. participating in other clinical trials in the past 1 months

Keywords: time-restricted feeding type 2 diabetes mellitus
women with asymptomatic endometrial hyperplasia

Conditions: Endometrial Hyperplasia

Summary: the purpose of this study is to evaluate the clinical meaning of an endometrial hyperplasia diagnosed using a vaginal ultrasound during routine gynecological examination.


Eligibility criteria:
inclusion criteria: * asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound exclusion criteria: * postmenopausal bleeding
ketorolac levels in vitreous and aqueous samples from patients undergoing combined cataract and pars plana vitrectomy surgeries with and without intracameral phenylephrine 1.0% / ketorolac 0.3%

Conditions: Cataract

Summary: this is a clinical trial evaluating ketorolac levels in vitreous and aqueous humor samples from patients undergoing combined cataract and pars plana vitrectomy surgeries with and without intracameral phenylephrine 1.0% / ketorolac 0.3% (omidria). patients not receiving intracameral omidria will receive topical ketorolac prior to cataract surgery/pars plana vitrectomy.

cataract surgery can result in intra- and postoperative inflammation. various strategies are employed to prevent and combat this inflammatory reaction, including preoperative topical nsaids, intraoperative nsaids or steroids, and postoperative topical nsaids and/or steroids. the only fda-approved nsaid for intraoperative use is the ketorolac component of omidria® (rayner surgical, bellevue, wa, usa). animal studies have assessed the concentration of ketorolac in the vitreous and demonstrated therapeutic levels out to 10 hours postoperatively. there is no human data for ketorolac levels in the vitreous following intracameral administration of omidria at the time of cataract surgery. this study will enroll approximately 10-20 patients undergoing combined cataract surgery immediately followed by pars plana vitrectomy. aqueous and vitreous samples will be taken intraoperatively and sent to an independent lab for analysis of ketorolac concentrations.

Eligibility criteria:
inclusion criteria: 1. able to provide informed consent 2. undergoing cataract surgery immediately followed by pars plana vitrectomy 3. diagnosed preoperatively with a structural pathology requiring vitrectomy (e.g., epiretinal membrane, macular hole, and symptomatic vitreous floaters) 4. willing and able to comply with all study procedures 5. male or female, aged ≥ 18 years exclusion criteria: 1. age \< 18 2. participating in another clinical trial 3. patients undergoing cataract surgery or pars plana vitrectomy alone (not a combined procedure) 4. previous vitrectomy 5. complications at the time of cataract surgery 6. a tear in the posterior capsule
phase iii study to evaluate the efficacy and safety of hob-048 cr tab. in comparison with hob-048 syrup in patients with cough due to acute or chronic bronchitis

Conditions: Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis

Summary: a randomized, double-blind, multicenter, active-controlled phase iii study to evaluate the efficacy and safety of levotuss cr tab. in comparison with levotuss syrup in patients with cough due to acute or chronic bronchitis


Eligibility criteria:
inclusion criteria: * moderate, severe, very severe non-productive cough patients exclusion criteria: * patients receiving a concomitant therapy
genetic characteristics of her2 positive breast cancer with neoadjuvant tchp chemotherapy

Conditions: HER2-positive Breast Cancer; Chemotherapy Effect; Circulating Tumor DNA

Summary: locally advanced breast cancer (labc) is defined as breast cancer (bc) larger than 5 centimeters or with lymph node metastasis. usually, labc is treated with neoadjuvant chemotherapy (nac) followed by curative surgery to reduce tumor size and eliminate micrometastasis. response to nac helps predict bc prognosis. pathologic complete response (pcr), defined as no residual tumor cells after nac, represents prolonged survival without bc recurrence and residual cancer burden score, based on residual tumor volume, and can more accurately predict bc outcomes. especially, human epidermal growth factor receptoor type 2(her2)-positive breast cancer, having aggressive biologic characteristics, was mostly treated by nac because of recent advance of highly effective targeted agents (pertuzumab and trastuzumab). however, still 30-40% of her2-positive breast cancer did not response to nac and underwent disease recurrence. recently, genetic studies to find biomarker of bc prognosis have been widely performed. circulating tumor dna (ctdna), which is circulating free dna in the blood that originates from cancers, can be detected by recently-developed technologies. ctdna could facilitate early disease detection, diagnosis and detection of disease recurrence. ctdna also provides a genomic profile of bc and predicts drug response. in bc, ctdna correlates with tumor burden and provides early detection of treatment response and tumor genetic alterations. in this study, the investigator aimed to identify the correlations in genomic profile between tumors and ctdna during nac(docetaxel /carboplatin /trastuzumab and pertuzumab) in her2 positive breast cancer.


Eligibility criteria:
inclusion criteria: * her2+ breast cancer * stage iia - iiic * plan to receive neoadjuvant chemotherapy with docetaxel, carboplatin, herceptin, perjeta * sign to informed consent exclusion criteria: * double primary cancer
amino acid infusion in kidney transplant recipients

Conditions: Short-term Graft Function; Metabolic Effects; Nutritional Effect; Immunological &Amp; Inflammatory Markers; Safety; Adverse Events

Summary: the study addresses the impact of amino acid infusion in the early post-transplant period on graft function and the incidence of post-transplant complications.

background and rationale: delayed graft function (dgf) remains a significant challenge in kidney transplantation, particularly in recipients of deceased donor organs. dgf, often defined as the need for dialysis within the first post-transplant week, is associated with poorer long-term graft survival and increased immunological risk. ischemia-reperfusion injury (iri) plays a crucial role in the pathogenesis of dgf, contributing to oxidative stress, inflammation, and endothelial dysfunction. strategies to mitigate iri and enhance early graft recovery are highly sought after. amino acids play a critical role in cellular metabolism, protein synthesis, and immunomodulation. prior research suggests that amino acid supplementation may improve nitrogen balance, enhance mitochondrial function, and reduce oxidative stress, potentially benefiting graft recovery. however, there is limited clinical evidence assessing whether perioperative amino acid administration improves graft function in kidney transplant recipients. the aid-kt study aims to evaluate the impact of intravenous amino acid infusion on early graft function following kidney transplantation. study design: aid-kt is a prospective, interventional cohort study with a retrospective control group. the intervention group will receive intravenous amino acid (aa) supplementation at a dose of 1g/kg body weight daily for three days post-transplant. the historical control group consists of kidney transplant recipients from previous years who did not receive amino acid infusion. the study will evaluate graft function, metabolic response, and patient outcomes over a 12-month follow-up period.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) undergoing deceased or living donor kidney transplantation * first-time kidney transplant recipients * no known allergy or contraindication to amino acids * stable hemodynamic status post-transplant * signed informed consent exclusion criteria: * patients requiring immediate dialysis post-transplant * multi-organ transplant recipients * severe hepatic dysfunction (child-pugh c) * uncontrolled infection or sepsis * malignancy within the past 5 years (except non-melanoma skin cancer) * prior participation in conflicting clinical trials

Keywords: kidney transplantation aminoacids delayed graft function diabetes mellitus acute graft rejection estimated glomerular filtration rate